For sterilizing filters used in pharmaceutical processes, a critical evaluation factor is the safety of the filter medium/device. Filter manufacturers typically provide information regarding the sourcing and toxicity of filter components, including the origin of animal-derived components.
Toxicity
Filters must not exert toxic effects on the medium to be filtered. Filter manufacturers typically qualify filters using standardized tests that comply with pharmacopeial methods. Generally, filter extracts or actual filter samples are introduced into animal or cell culture systems for testing. The reactivity of the animals or cell cultures to the test article is evaluated and compared against predefined acceptance criteria for toxicological safety. The results of these tests are typically included in filter validation guides.
Animal-Derived Materials
Filter manufacturers typically disclose information regarding animal-derived materials used in filter production. The use of tallow-derived stearates poses virtually no risk of transmitting Transmissible Spongiform Encephalopathy (TSE) or other diseases. Generally, the manufacturing processes for tallow and tallow derivatives should be highly stringent, meeting or exceeding applicable safety requirements.